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. 2023 Nov 9;47(2):253–262. doi: 10.1007/s00270-023-03602-y

Table 1.

Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
Age > 18 years Extrahepatic disease
Performance status (ECOG 0–2 or ASA 1–3) MSI/dMMR
Histological documentation of primary colorectal tumour (adenocarcinoma) Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume)
Local treatment performed for initial CRLM Compromised liver function (e.g. signs of portal hypertension, INR > 1.5 without use of anticoagulants, ascites)
New recurrence ≤ 12 months Uncontrolled infections (> grade 2 NCI-CTC version 3.0)
 ≥ 1 locally treatable CRLM (resectable* and/or ablatable) Pregnant or breast-feeding subjects
Total number of new CRLM ≤ 5 Immuno- or chemotherapy ≤ 6 weeks prior to the randomization
Chemo-naïve or history of response to CAPOX/FOLFOX/FOLRIRI Severe allergy to contrast media not controlled with premedication
Life expectancy of at least 12 weeks Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results

Adequate bone marrow, liver and renal function:

 Haemoglobin ≥ 5.6 mmol/L

 Absolute neutrophil count (ANC) ≥ 1,500/mm3

 Platelet count ≥ 100*109/l

 Total bilirubin ≤ 1.5 times the upper limit of normal

 ALT and AST ≤ 2.5 × upper limit of normal (≤ 5 × upper limit of normal for subjects with liver involvement of their cancer)

 Albumin > 30 g/l

 Serum creatinine ≤ 1.5 × upper limit of normal or a MDRD ≥ 50 ml/min

 Prothrombin time or INR < 1.5 × ULN, unless coumarin derivates are used. Due to interactions with capecitabine, all patients using coumarin derivates will be treated with LMWH instead

 Activated partial thromboplastin time < 1.25 × ULN (therapeutic anticoagulation therapy is allowed if this treatment can be interrupted as judged by the treating physician)

Written informed consent

ECOG Eastern Cooperative Oncology Group, ASA American Society of Anesthesiologists, MSI Microsatellite instability, dMMR deficient mismatch repair

*Resection for resectable lesions considered possible by obtaining negative resection margins (R0) and preserving adequate liver reserve